Note: This document contains side effect information about alemtuzumab. Some dosage forms listed on this page may not apply to the brand name Campath.
Summary
Common side effects of Campath include: herpes simplex infection, opportunistic infection, and thrombocytopenia. Continue reading for a comprehensive list of adverse effects.
Applies to alemtuzumab: intravenous solution.
Warning
Intravenous route (Solution)
Cytopenias, Infusion-related Reactions, and InfectionsSerious, including fatal, cytopenias, infusion-related reactions, and infections can occur.Limit doses to 30 mg (single) and 90 mg (cumulative weekly); higher doses increase risk of pancytopenia.Escalate dose gradually and monitor patients during infusion. Withhold therapy for Grade 3 or 4 infusion-related reactions.Administer prophylaxis against Pneumocystis jirovecii pneumonia (PCP) and herpes virus infections.
Intravenous route (Solution)
Autoimmunity, Infusion Reactions, Stroke, and MalignanciesAlemtuzumab causes serious, sometimes fatal, autoimmune conditions such as immune thrombocytopenia and anti-glomerular basement membrane disease. Monitor complete blood counts with differential, serum creatinine levels, and urinalysis with urine cell counts before starting treatment and then at monthly intervals until 48 months after the last does of alemtuzumab.Alemtuzumab causes serious and life-threatening infusion reactions. Alemtuzumab must be administered in a setting with appropriate equipment and personnel to manage anaphylaxis or serious infusion reactions. Monitor patients for two hours after each infusion. Make patients aware that serious infusion reactions can also occur after the 2-hour monitoring period.Serious and life-threatening stroke (including ischemic and hemorrhagic stroke) has been reported within 3 days of alemtuzumab administration. Instruct patients to seek immediate medical attention if symptoms of stroke occur.Alemtuzumab may cause an increased risk of malignancies, including thyroid cancer, melanoma, and lymphoproliferative disorders. Perform baseline and yearly skin exams.Because of the risk of autoimmunity, infusion reactions, and malignancies, alemtuzumab is available only through restricted distribution under a Risk Evaluation Mitigation Strategy (REMS) Program. Call 1-855-676-6326 to enroll in the alemtuzumab REMS program.
Serious side effects of Campath
Along with its needed effects, alemtuzumab (the active ingredient contained in Campath) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking alemtuzumab:
More common
- Black, tarry stools
- blood in the urine
- chest tightness
- chills
- cough
- diarrhea
- dizziness, fainting, or lightheadedness when getting up suddenly from a lying or sitting position
- fast heartbeat
- fever
- headache
- itching, hives, skin rash
- nausea
- painful or difficult urination
- pale skin
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- sweating
- swollen glands
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting
Less common
- Bloating or swelling of the face, hands, lower legs, or feet
- chest pain
- hoarseness
- lower back or side pain
- muscle weakness
- painful cold sores or blisters on the lips, nose, eyes, or genitals
- pounding or irregular heartbeat or pulse
- rapid weight gain
- red or purple spots on the skin, varying in size and remaining after pushing the skin surface
- tremor
- unexplained nosebleeds
Rare
- Bloody nose
- flushing of the face or neck
- swelling of the eyelids, face, or lips
- white patches on the tongue, in the mouth, or in the folds of the skin, including the genitals
Incidence not known
- Anxiety
- back pain
- blindness
- blurred or double vision
- chest pain or discomfort
- confusion
- dark urine
- decreased urine output
- decreased vision
- difficulty in speaking
- dilated neck veins
- discouragement
- double vision
- drowsiness
- extreme tiredness or weakness
- eye pain
- feeling of discomfort
- feeling sad or empty
- general feeling of tiredness and weakness
- inability to move the arms, legs, or facial muscles
- inability to speak
- irregular breathing
- irritability
- joint pain, stiffness, or swelling
- lack of appetite
- light-colored stools
- loss of interest or pleasure
- muscle aches or pain
- nightmares or unusually vivid dreams
- numbness, pain, tingling, or weakness
- pain or discomfort in the arms, jaw, back, or neck
- painful or tender lymph glands in the neck, armpit, or groin
- seizures
- shakiness and unsteady walk
- slow speech
- spitting or coughing up blood
- stiff neck
- sudden numbness and weakness in the arms and legs
- swelling of the face, fingers, feet, or lower legs
- trouble concentrating
- trouble sleeping
- unsteadiness, trembling, or other problems with muscle control or coordination
- upper right abdominal or stomach pain and fullness
- yellow eyes and skin
Other side effects of Campath
Some side effects of alemtuzumab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Fear or nervousness
Less common
- Belching
- bone pain
- burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
- heartburn
- indigestion
- lack or loss of strength
- stomach discomfort, upset, or pain
- swelling or inflammation of the mouth
- weight loss
Rare
- Constipation
- sensation of temperature change
- sleepiness
- stuffy nose
For Healthcare Professionals
Applies to alemtuzumab: intravenous solution.
Hematologic
Very common (10% or more): Lymphopenia (97%), neutropenia (77%), anemia (76%), thrombocytopenia (71%), granulocytopenia
Common (1% to 10%): Decrease in CD4 lymphocytes, decrease in CD8 lymphocytes, decrease in T-lymphocyte count, febrile neutropenia, pancytopenia, leukopenia, lymphopenia, purpura
Uncommon (0.1% to 1%): Aplasia bone marrow, disseminated intravascular coagulation, hemolytic anemia, decreased haptoglobin, bone marrow depression, hematology test abnormal[Ref]
Immunologic
Very common (10% or more): Immunogenicity (up to 83%), herpes viral infection (16%), fungal infection (13%), sepsis, cytomegalovirus infection, cytomegalovirus
viremia
Common (1% to 10%): Influenza, neutropenic fever
Uncommon (0.1% to 1%): Sepsis, staphylococcal bacteremia, tuberculosis, beta hemolytic streptococcal infections, candidiasis, genital candidiasis, body tinea
Very rare (less than 0.01%): Immune thrombocytopenia
Frequency not reported: Autoimmunity[Ref]
Respiratory
Very common (10% or more): Nasopharyngitis (25%), upper respiratory tract infection (16%), sinusitis (11%), pneumonia
Common (1% to 10%): Cough, dyspnea, bronchitis, chest discomfort, epistaxis, hypoxia, hemoptysis, bronchospasm
Uncommon (0.1% to 1%): Stridor, throat tightness, pulmonary infiltration, pleural effusion, breath sounds decreased, respiratory disorder
Frequency not reported: Respiratory alkalosis[Ref]
Gastrointestinal
Very common (10% or more): Nausea (21%), diarrhea (12%), oropharyngeal pain (11%), abdominal pain (10%), vomiting (10%)
Common (1% to 10%): Dyspepsia, gastrointestinal hemorrhage, ulcerative stomatitis, stomatitis, gastroenteritis, tongue ulceration, gingivitis, hiccup, eructation, dyspepsia, constipation, flatulence, oral candidiasis
Uncommon (0.1% to 1%): Gingival bleeding, dry mouth, paralytic ileus, oral discomfort
Frequency not reported: Duodenal ulcer, intestinal perforation, melena, peptic ulcer, pseudomembranous colitis, colitis, pancreatitis, peritonitis[Ref]
Nervous system
Very common (10% or more): Headache (52%), insomnia (16%), paresthesia (10%), dizziness (10%)
Common (1% to 10%): Dysgeusia, vertigo, tremor, paresthesia, hypoesthesia, hyperkinesia, taste loss
Uncommon (0.1% to 1%): Syncope, abnormal gait, dystonia, hyperesthesia, neuropathy, taste perversion[Ref]
Cardiovascular
Very common (10% or more): Hypotension, hypertension
Common (1% to 10%): Tachycardia, peripheral edema, vasospasm
Uncommon (0.1% to 1%): Cardiac arrest, myocardial infarction, atrial fibrillation, supraventricular tachycardia, arrhythmia, bradycardia, abnormal ECG, peripheral ischemia, cyanosis, orthostatic hypotension, hot flush
Frequency not reported: Congestive heart failure, cardiomyopathy, decreased ejection fraction in non-MS patients previously treated with potentially cardiotoxic agents[Ref]
Musculoskeletal
Very common (10% or more): Arthralgia (12%), pain in extremity (12%), back pain (12%)
Common (1% to 10%): Chills, muscular weakness, muscle spasms, myalgia, neck pain, arthralgia, skeletal pain, back pain
Uncommon (0.1% to 1%): Leg pain, hypertonia, muscle spasms
Frequency not reported: Arthritis or worsening arthritis, bone fracture, myositis, muscle atrophy, osteomyelitis, polymyositis, skeletal pain[Ref]
Dermatologic
Very common (10% or more): Rash (53%), urticaria (16%), pruritus (14%)
Common (1% to 10%): Dermatitis, erythema, hyperhidrosis, bullous eruption, erythematous rash
Uncommon (0.1% to 1%): Maculopapular rash, skin disorder[Ref]
Endocrine
Very common (10% or more): Thyroid gland disorders (13%)[Ref]
Hepatic
Frequency not reported: Hyperbilirubinemia, hepatic failure, hepatocellular damage, hypoalbuminemia, biliary pain[Ref]
Metabolic
Very common (10% or more): Anorexia
Common (1% to 10%): hyponatremia, hypocalcemia, weight decrease, dehydration, thirst
Uncommon (0.1% to 1%): Hypokalemia, diabetes mellitus aggravated
Frequency not reported: Thyroid disorder, fluid overload[Ref]
Oncologic
Frequency not reported: Malignancies (e.g., malignant lymphoma, malignant testicular neoplasm, prostatic cancer, plasma cell dyscrasias, secondary leukemia, squamous cell carcinoma)[Ref]
Genitourinary
Very common (10% or more): Urinary tract infection (19%)
Common (1% to 10%): Blood in urine, abnormal uterine bleeding
Uncommon (0.1% to 1%): Impotence, urinary incontinence, urine flow decreased, polyuria, cystitis
Frequency not reported: Cervical dysplasia[Ref]
Other
Very common (10% or more): Pyrexia (29%), fatigue (18%), flushing (10%)
Common (1% to 10%): Asthenia[Ref]
Renal
Uncommon (0.1% to 1%): Renal function abnormal
Frequency not reported: Acute renal failure[Ref]
Ocular
Common (1% to 10%): Conjunctivitis
Uncommon (0.1% to 1%): Endophthalmitis[Ref]
Hypersensitivity
Uncommon (0.1% to 1%): Allergic reaction
Frequency not reported: Anaphylactoid reaction[Ref]
Local
Uncommon (0.1% to 1%): Infusion site bruising, infusion site dermatitis, infusion site pain
Frequency not reported: Infusion reactions (e.g., anaphylaxis, angioedema, bronchospasm, hypotension, chest pain, bradycardia, tachycardia (including atrial fibrillation), hypoxia, syncope, acute respiratory distress syndrome, respiratory arrest, myocardial infarction, acute cardiac insufficiency, cardiac arrest, transient neurologic symptoms, hypertension, headache, pyrexia, rash, nausea, urticaria, pruritus, insomnia, chills, flushing, fatigue, dyspnea, pulmonary infiltrates, dysgeusia, dyspepsia, dizziness, pain)[Ref]